Devices, systems, and methods for cleaning, disinfecting, rinsing, and priming blood separation devices and associated fluid lines

ABSTRACT

Systems and methods for providing for the automatic instrument-based rapid reprocessing of an intact extracorporeal circuit for use in hemodialysis. The system includes a manifold with connectors for engaging a dialyzer as well as venous and arterial blood lines. The manifold is adapted to be moved from a dialysis machine to a reuse instrument without removing the dialyzer and associated blood lines. The system allows for reprocessing of the extracorporeal circuit wherein prior to the next treatment, there is no residual chemical disinfectant requiring testing, the extracorporeal circuit is pre-primed, the levels in the bubble traps are set, and all of the required quality assurance tests are performed and recorded.

FIELD OF THE INVENTION

The invention is directed to devices, systems and methods for cleaning,disinfecting or rendering aseptic, rinsing, and priming for reuse medialdevices for blood treatment, such as hemodialyzers, hemofilters, andplasmafilters, and their associated fluid lines which may convey bloodor other fluids such as saline or heparin.

BACKGROUND OF THE INVENTION

Reuse of hemodialyzers is the standard practice in the field, havingbeen first employed in the mid 1960's. Currently, in the United States,over 80% of all dialysis procedures are preformed with reused.artificial kidneys. Standards for this practice were established by theAssociation for the Advancement of Medical Instrumentation (AAMI) in themid 1980's and were later embraced by the Food and Drug Administrationwho subsequently published their own guidance document regardingdialyzer reuse.

Dialyzer reuse has been necessitated by lack of funding. Federal fundinghas been decreased in inflation-adjusted dollars by more than 90% sinceit was enacted in 1972. There are also documented clinical benefits todialyzer reuse related to the prevention of humoral reactions to thematerials of construction of the devices. Some of these reactions, suchas acute anaphylaxis, can be lethal.

Reuse of the associated blood tubing sets is also known but much lessfrequently practiced because of the problems inherent with current reusepractices. When reuse of blood tubing is attempted in a clinicalsetting, it is only the arterial half of the pair that is reused sinceclot filtering screens are almost universally present in the bubbletraps of the venous line which are very difficult to clean afterexposure to blood. The ubiquity of these screens is notwithstanding thecomplete absence of evidence supporting their utility and the presenceof data indicting these components as the source of clot formation onthe downstream side of their surface thereby creating the exact problemthey are implemented to prevent. Consequently, there are nowcommercially available venous blood tubing lines which contain no filterscreen in the bubble trap and yet others which contain no bubble trap orclot filtering screen.

Reuse may be accomplished either manually, using apparatus designed andbuilt by the dialysis provider, or by automated instruments which arecommercially available. Although techniques vary somewhat, through theefforts of AAMI and HCFA (Health Care Finance Administration, now CMS),considerable standardization has occurred. Several quality assurancesteps must be taken in order to qualify for federal reimbursement. Theseinclude assuring that: the proper concentration of disinfectant is usedand that its residence time and duration are adequate, the disinfectantis rinsed out to acceptably low levels prior to the next use, thedialyzer is only used on the same patient, the small molecule transportrate is within 10% of its original value, and the device does not leak.

The various disinfectants that are used include formaldehyde, peraceticacid/hydrogen peroxide, heat, hot citric acid, and glutaraldehydes.Also, bleach and hydrogen peroxide are sometimes employed as oxidizingagents to both cleanse the dialyzers of retained organic material andimprove their esthetic appearance. This can be important since the reusestandards stipulate that patients can refuse to reuse a dialyzer for anyreason, including its appearance.

The economic pressures on providers of dialysis therapy continue toworsen worldwide as funding continues to be reduced. This is amplifiedby the continued inflation in labor and operating costs. The result is acontinual search on the part of providers to reduce their costs andimprove their efficiency. Even with the use of automated equipment,there is still a relatively large labor component attached to each reuseand, as previously noted, in the vast majority of cases only thedialyzer is reused with the blood tubing sets, needles, and IV setsstill being discarded with every treatment.

Additionally, prior to each dialysis procedure, a member of the clinic'sstaff must still spend time assembling new blood tubing sets to thedialyzer, priming the air out of this extracorporeal circuit, settingthe correct fluid level in the bubble traps, adjusting the dialysismachine to rinse (dialyze) the disinfectant out of the circuit, and,finally, performing a manual test of the priming solution to assure thatthe residual disinfectant level is below acceptable limits. In addition,there is a cost to train new employees who are involved in the reuseprocess and, since there is a fairly high turnover rate for these typesof employees, this cost is not insignificant.

It is therefore desirable to provide a method and associated deviceswhich-could reduce the labor and supplies costs of providing dialysistreatments in clinical settings.

U.S. Pat. Nos. 4,552,721 and 4,707,335 to Fentress et al. describes thesimultaneous reprocessing of the blood treatment device and itsassociated and connected blood tubing and other fluid lines without anyinstrumentation. However, the lack of instrumentation results in theinability to perform the quality assurance tests for small molecule andwater transport rates and membrane integrity. Also, the unavailabilityof high flows and pressures, as can be applied with an instrument,eliminates the opportunity to remove residual organic material by shearforces.

It is therefore desirable to provide a reuse system withinstrumentation, in order to provide high flows and pressures.

U.S. Pat. No. 4,695,385 to Boag describes an apparatus which wasdesigned to also allow the simultaneous reprocessing of the dialyzer andassociated blood tubing sets while they remained connected to, thedialysis machine. However, this ties up the dialysis machine during thereprocessing procedure, rendering the system non-viable for use in adialysis clinic where it is necessary to treat multiple patients on thesame machine in a day. This system has, therefore, been relegated tohome use exclusively.

Similarly, U.S. Pat. No. 6,132,616 to Twardowski et al. describes asystem where the dialyzer and connected blood tubing sets (theextracorporeal circuit) remain on the dialysis machine (which doubles asan automated reuse instrument) between treatments as it disinfects notonly the extracorporeal circuit, but the dialysate and waterpurification fluid pathways simultaneously with hot water. Once again,this restricts the use of this system primarily to extra-clinicalsettings where only one patient will be using the dialysis instrument.

It is therefore desirable to provide a system that reprocesses thedialyzer and associated blood tubing away form the dialysis machine.

In-center hemodialysis is generally performed three times per week forbetween three and five hours. This means that each hemodialysis machinecan treat approximately two cycles of 3-4 patients for a total of 6-8patients per week. However, it is becoming apparent that dailyhemodialysis is the gold standard of care. In this method, hemodialysisis typically performed six days a week for between two to three hours.Daily hemodialysis more closely resembles normal kidney function thantreatment three times a week. This means that patients have fewernegative side effects, and may also reduce some of the dietaryrestrictions and medications for patients.

As discussed above, most artificial kidneys are cleaned, sanitized, andreused. However, the blood tubing is generally not reused. Currently,Medicare as well as commercial insurer payments are based on the threetreatments per week. Therefore, daily hemodialysis is not feasiblein-center because of the added cost of the incremental blood tubingcircuits and the associated time and labor required to set-up andtear-down the extracorporeal circuit between patient shifts. The currentreimbursement system, along with the inability to effectively andtime-efficiently reuse the venous and arterial blood lines are the mainbarriers to patients receiving the gold standard of care in clinics.Therefore it is desirable to provide a system that cleans and sanitizesblood tubing for reuse and to do so expediently so that two patientshifts could potentially be performed within approximately the sametimeframe as a single shift is currently accomplished including theset-up and tear-down time.

SUMMARY OF THE INVENTION

The invention provides systems and methods for automatically cleaning,disinfecting, and priming a medical device such as a blood separationdevice.

The system includes a blood separation device having a blood flow pathand a dialysate fluid flow path. The system may also include a bloodinlet line which delivers blood from the patient to the blood separationdevice. The system may further include a blood outlet line which returnsblood from the blood separation device to the patient. The system mayfurther include a manifold. The manifold may be coupled to the bloodseparation device. The manifold may include a plurality of connectorsfor engaging the patient end of the blood inlet line and the bloodoutlet line. The system may also include a reuse instrument. Themanifold may be coupled to the reuse instrument to clean, disinfect,test, and prime the blood inlet and outlet lines and the bloodseparation device.

Another aspect of the invention provides a method including providing adialysis machine, a blood separation device, a blood inlet line, a bloodoutlet line and a manifold. The method may further include coupling theblood separation device to the manifold, the blood inlet and outletlines to the blood separation device, and the manifold to the dialysismachine. The method may further include connecting the blood inlet andoutlet lines to a patient and providing dialysis treatment to thepatient.

The method may further include removing the blood inlet and outlet linesfrom the patient and removing the manifold from the dialysis machine.The method may further include coupling the ends of the blood inlet andoutlet lines to the manifold, coupling the manifold to a reuseinstrument, and reprocessing the blood inlet and outlet lines and theblood separation device.

Another aspect of the invention provides a method of providinghemodialysis in a clinical setting. The method includes providing adialysis machine, a reuse instrument, a first patient dialysis set and asecond patient dialysis set. The method further includes coupling thefirst patient dialysis set to the dialysis machine and providingdialysis treatment to a first patient. The method may further includeremoving the first patient dialysis set from the dialysis machine,coupling the first patient dialysis set to the reuse instrument, andreprocessing the first patient dialysis set.

The method may further include coupling the second patient dialysis setto the dialysis machine and providing dialysis treatment to a secondpatient. The method may further include removing the first patientdialysis set from the reuse instrument and storing the first patientdialysis. The method may further include removing the second patientdialysis set from the dialysis machine, coupling the second patientdialysis set to the reuse instrument, and reprocessing the secondpatient dialysis set.

Other features and advantages of the invention shall be apparent basedupon the accompanying description, drawings, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic of a general hemodialysis circuit.

FIG. 2 is perspective view of a manifold according to the presentinvention.

FIG. 3 is a front plan view of the manifold of FIG. 2 coupled to anextracorporeal circuit for use in hemodialysis.

FIG. 4 is a front plan view of the manifold and associatedextracorporeal circuit of FIG. 3 coupled to a dialysis machine.

FIG. 5 is a front plan view of the manifold and associatedextracorporeal circuit of FIG. 3 coupled to a reuse machine.

FIG. 6 is a schematic of a method according to the present invention forhemodialysis and reprocessing in a clinical setting.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Although the disclosure hereof is detailed and exact to enable thoseskilled in the art to practice the invention, the physical embodimentsherein disclosed merely exemplify the invention which may be embodied inother specific structures. While the preferred embodiment has beendescribed, the details may be changed without departing from theinvention, which is defined by the claims.

The current invention provides for the automatic instrument-based rapidreprocessing of the intact extracorporeal circuit 12 where, prior to thenext treatment, there is no residual chemical disinfectant requiringtesting, the extracorporeal circuit 12 is pre-primed with sterileelectrolyte solution supplied by the reuse instrument 72, the levels inthe bubble traps 38 if present are set, and all of the required qualityassurance tests are performed and recorded. By so doing, much of theresidual labor component for setting up each next dialysis treatment iseliminated and the cost of the blood tubing sets 16, 18 is dramaticallyreduced. Also, the degree of training for reuse technicians is reduced.

Hemodialysis is a procedure in which a machine filters harmful waste andexcess electrolytes and fluid from your blood. FIG. 1 shows a simplifiedhemodialysis system. Most hemodialysis systems consist of an artificialkidney, also known as a dialyzer 10, connected to an extracorporealblood circuit 12 and a dialysate circuit 14. The dialyzer 10 isessentially a filter. In the illustrated embodiment the dialyzer 10generally comprises a case which encloses a bundle of hollow fibersemi-permeable membranes, however any type of filter used in the artcould be utilized. The dialyzer 10 is connected to an arterial (inflow)blood line 16 and a venous (outflow) blood line 18. The three componentstogether form an extracorporeal blood circuit. The dialyzer 10 has ablood inlet 20 and a blood outlet 22 as well as a dialysate inlet 24 anda dialysate outlet 26.

The arterial line 16 carries blood from the patient 70 to the dialyzer10. The arterial line 16 includes a patient end 28 and a device end 30.The patient end 28 is attached to the patient 70 using any type ofconnection means known in the art. The device end 30 is attached to theinlet 20 of the filter 10 using any type of connection means known inthe art. The arterial line 16 generally includes a pump section 32 andat least one side arm 34 leading to a pressure monitor 36. The arterialline 16 may also include at least one air trap 38 associated with thepressure monitor 36. The arterial line 16 may also include a side arm 40leading to a saline source 42 and/or a side arm 42 leading to ananticoagulant source 46. The arterial line 16 may also include at leastone injection site 48 for drawing blood and/or injecting drugs.

The venous line 18 carries the newly dialyzed blood away from thedialyzer 10 and back to the patient 70. The venous line 18 includes apatient end 51 and a device end 49. The patient end 51 is attached tothe patient 70 using any type of connection means known in the art. Thedevice end 49 is attached to the outlet 22 of the filter 10 using typeof connectors known in the art. The venous line 18 may include at leastone side arm 34 leading to a pressure monitor 36. The venous line 18 mayfurther include an air trap 38 associated with the pressure monitor 36.

The dialyzer 10 is also connected to a dialysate circuit 14. Thedialysate circuit 14 is well known in the art. In its essence thedialysate circuit 14 includes a dialysate source 52 and a pump 54 topush the dialysate through the filter 10. However, as is known in theart, it is common to find the dialysate source 52 and pump 54 attachedto the dialysis machine 66 such that the dialysis process may bemonitored.

The present invention generally comprises a system and method forcleaning, disinfecting or rendering aseptic, rinsing, and priming bloodtreatment devices. The invention preferably comprises a manifold 56 towhich the dialyzer 10 may be attached so that all components of theextracorporeal circuit could be transported as a single unit. Themanifold 56 is preferably sized and configured such that the dialysateports 24,26 of the dialyzer 10 and all fluid lines 16,18 of theextracorporeal circuit 12 are connected to the manifold 56 prior to theextracorporeal circuit 12 being removed from the dialysis equipment 66at the termination of a treatment. The various fluid lines 16,18,including all side arms 34, 40, 44, 50 are then in fluid connection witheach other and a reuse instrument 72 in order to clean and prepare theextracorporeal circuit 12 for reuse.

The manifold 56 may include a connector 60 for the patient end 28 of theblood inlet line 16 and the patient end 51 of the blood outlet line 18.The manifold 56 may also include connectors 60 for the ends of any fluidside arms connected to the blood inlet 16 and/or outlet 18 lines. Forexample, the manifold may include a connector 60 for a saline side arm40, a connector 60 for a medication sidearm 44, and a connector 60 forthe pressure sensing side arms 34, 50. The manifold 56 also preferablyincludes connectors 62 that communicate with the dialysate inlet 24 andthe dialysate outlet 26 located on the dialyzer 10.

The manifold provides fluid communication pathways between each bloodline 16,18 and all side arms 34,30,44,50 and the automated reuseinstrument 72 to which the manifold 56 may be mated. The manifold 56 maybe further designed to provide a fluid communication pathway between thedialysate inlet 24, dialysate outlet 26, and an automated reuseinstrument 72 to which the manifold 56 may be mated. It is contemplatedthat this fluid pathway may be provided by allowing the dialysate inlet24 and outlet 26 connectors to pass through the manifold 56 and engagethe automated reuse machine 72 directly.

It is also contemplated that the manifold 56 may be designed in such away that when the dialysate inlet 24 and outlet 26 ports of the dialyzer10 are mated to the manifold 56, fluid egress from the dialysate circuitof the dialyzer 10 is prevented until it is mated with the reuseinstrument 72. It is also contemplated that the dialysate inlet 24 andoutlet 26 ports of the dialyzer 10 connect to the reuse instrument 72 inthe same way that they connect to the dialysis machine 66 (for example,via hoses terminating in Hansen connectors) where the manifold 56 is notinvolved in this mating at all.

The type of connections 60 used in the manifold 56 would depend on thetype of fitting used on the extracorporeal circuit 12. For example, if amale luer connector is used at the patient end 28 of the arterial line16, the connector 60 in the manifold 56 should be a female luerconnector. In this manner the manifold may be design and adapted to fitany available type of tubing circuits 16,18 by simply providing theappropriate number of mating connections 60 for the connections presenton the tubing circuits 16,18.

The manifold 56 may also include means 64 to allow the various pieces oftubing 16,18 and bubble traps 38 to be organized in a logical andcompact manner. The tubing and bubble traps may be coupled to themanifold using any known means.

In use, the manifold 56 is coupled to the dialyzer 10. The manifold 56may be coupled to the dialysis machine 66, thus attaching the dialysatecircuit 14 to the dialyzer 10. The arterial circuit 16 and the venouscircuit 18 are each coupled to the manifold 56 using any type ofconnector means known in the art. Any side arms 34,30,44,50 may beattached to the appropriate device using any type of connector meansknown in the art. For example, the pressure monitoring side arms 34,36are attached to the pressure sensors 36, the saline side arm 40 isattached to the saline source 42, and the anti-coagulant side arm 44 isattached to the anti-coagulant source 46. The extracorporeal bloodcircuit 12 may then be attached to the patient 70 as is known in theart. The dialysis treatment may then begin.

After dialysis is complete, the venous line 18 and arterial lines 16 aredisconnected from the patient 70. The patient end 51 of the venous line18 is then attached to a connector 60 on the manifold 56 and the patientend 28 of the arterial line 16 is attached to a second connector 60 onthe manifold 56. Any additional blood lines, such as venous 50 andarterial 34 pressure monitoring side arms, a saline infusion side arm40, and a Heparin infusion side arm 44 are also attached to associatedconnectors 60 on the manifold 56. The manifold 56, including thedialyzer 10 may then be removed from the dialysis machine 66 and placedon a separate reuse instrument 72, as shown in FIG. 5. The manifold 56is preferably sealingly mated to the reuse instrument 72. Preferably,the dialysate inlet 24 and outlet engage 26 the reuse instrument 72 whenthe manifold 56 is placed on the reuse instrument 72. The reuseinstrument 72 will then process both the dialyzer 10 and the associatedarterial line 16 and venous line 18.

In one embodiment, the fluid paths integral to the manifold 56 may bedesigned in such a way so as to prevent any further fluid egress oncethe various connections of the extracorporeal circuit are made to it.One method of accomplishing this would be to terminate the fluid pathsintegral to the manifold 56 on the side which will mate to the reuseinstrument 72 in female needleless connectors. Needleless connectors arewell known in the art (e.g. U.S. Pat. No. 5,100,394) and typicallyconsist of a male and female counterpart where the female counterpart istypically an injection site where the elastomeric septum (e.g. latex orsilicone rubber) is pre-split and compressed in a housing such that ablunt male cannula (as opposed to a sharp needle) may penetrate theseptum to accomplish injection or removal of a fluid while stillassuring that there is complete sealing around the male cannula. Thefemale needleless injection site termination points on the manifold 56may then mate to blunt male cannula counterparts on the reuse instrument72 such that when the manifold 56 is pushed onto the reuse instrument72; the fluid pathways internal to the manifold 56 are accessed allowingall fluid pathways of the extracorporeal circuit to also be accessed bythe reuse instrument 72. When the reuse process is complete and theextracorporeal circuit/manifold assembly is removed by pulling it awayfrom the reuse instrument 72, the female needleless injection sitesinstantly close preventing leakage of the sterile electrolyte solutioncontained therein. A similar design could be used in the connection ofthe dialyzer dialysate ports 24,26 to the reuse instrument 72.

It should also be understood that some inlet 16 and outlet 18 bloodlines may contain no bubble traps 38 or side arms 34,40,44,50 of anykind. In this case, there may be no need for a manifold 56 to accomplishthe method of extracorporeal circuit reuse herein described.Conventional blood tubing sets for hemodialysis are typically sold witha recirculation connector included in the sterile package. Thisrecirculation connector allows for the patient ends 28,51 of thearterial 16 and venous 18 blood lines to be connected together prior tothe start of a clinical treatment so that any residual disinfectant orpriming solution may be recirculated through the entire extracorporealcircuit under the control of the dialysis machine 66 thereby allowingresidual contaminants to be dialyzed away. This same recirculationconnector could be employed at the end of a clinical treatment to onceagain connect the patient ends 28,51 of the arterial 16 and venous 18blood lines together to insure no egress of fluid as the extracorporealcircuit is removed from the dialysis machine 66 and transported to thereuse instrument 72. Connection to the reuse instrument 72 in this casecould be as simple as connecting the dialyzer's dialysate inlet 24 andoutlets 26 ports to connectors on the reuse machine 72 that areidentical to those on the dialysis machine 66 (e.g. hoses terminating inHansen connectors) and the patient end connectors (male luers) of thetwo blood lines 16,18 could be inserted into mating counterparts on thereuse instrument 72 once disconnected from the recirculation connector.The connection of the blood lines 16,18 to the reuse instrument 72 wouldpreferably be locked in such a way to prevent these lines from blowingoff of the reuse instrument 72 under the positive pressure that wouldtypically be used to introduce fluid into the blood lines 16,18.

It should be understood that a closed blood circuit is formed by use ofeither the manifold or recirculation connector. It is furthercontemplated that the closed blood circuit may be formed by any meansknown in the art. For example, the closed blood loop may be created byclosing a clamp near the patient ends 28,51 of both the arterial 16 andvenous 18 blood lines.

The automated reuse instrument 72 may control the passage of variousfluids through all of the fluid pathways of the manifold 56 in anautomated manner in order to clean and disinfect the extracorporealcircuit 12. The entire extracorporeal circuit 12 may be tested for leaksby the instrument 72. The instrument 72 may also measure the solutetransport rate of the dialyzer 10, set the level of the bubble traps 38,leave the extracorporeal circuit primed with sterile electrolytesolution for the next treatment, and record, store, export and displayall required quality assurance data. This reduces the amount of time ittakes to prepare for a next dialysis session and allows the degree oftraining for reuse technicians to be reduced.

It should also be understood that the extracorporeal circuit may bemanually primed, off-line from the reuse instrument 72, at any point intime prior to treatment. If the extracorporeal circuit is primedoff-line, it would be preferable to do immediately prior to treatment toavoid contamination of the electrolyte solution.

It should also be understood that the system and methods describedherein allow for the reprocessing of the intact extracorporeal circuit12, including the venous segment 18, offline from the dialysis machine66 by a separate automated instrument 72. This system and method allowsthe venous 18 and arterial 16 lines of the extracorporeal circuit 12 tobe reused which not only makes daily hemodialysis feasible in a clinicalsetting, but also reduces the cost of standard three times a weektreatment.

For a single patient receiving dialysis treatment three times a week, aclinic currently would need to utilize 156 sets of venous 18 andarterial 16 lines per year. For daily treatment, this number jumps to312 sets of venous 18 and arterial 16 lines per year. Using the systemsand methods described herein, the clinic may use a single extracorporealcircuit 12 for each patient for 30 or more uses. This results inapproximately 10-11 extracorporeal circuits 12 being used per year foreach patient for daily treatment and 5-6 extracorporeal circuits 12 peryear for three times a week treatment. This is a savings of 150-300 setsof venous 18 and arterial 16 lines per year for a single patient.

Further, because a new set of arterial 16 and venous 18 lines do nothave to be attached to the dialyzer 10 prior to each dialysis treatment,there is reduced labor associated with the dialysis process. This mayfurther also result in fewer chances of user error (e.g. touchcontamination of the sterile fluid path) because the blood lines 16,18do not have to be reattached prior to each use.

It should be understood that the systems and methods of this inventionmay be particularly useful in a clinical setting. A clinic may have asingle dialysis machine 66 and a single reuse instrument 72. For eachpatient the clinic could then utilize an individual dialysis setcomprising a complete extracorporeal circuit 12, including a dialyzer10, coupled to a manifold 56. Each dialysis set is preferablyspecifically designated for use with a single patient. For example, ifthe clinic treats three patients, the clinic would have patient dialysisset A for patient A, patient dialysis set B for patient B, and patientdialysis set C for patient C.

Patient A may receive dialysis using patient dialysis set A attached tothe dialysis machine 66 in the manner described above. After patient A'sdialysis treatment is complete, patient dialysis set A is removed fromthe dialysis machine 66 and attached to the reuse instrument 72 forreprocessing. While patient dialysis set A is being reprocessed, patientdialysis set B may be attached to the dialysis machine 66 and patient Bmay receive dialysis treatment. After patient B's dialysis treatment iscomplete, patient dialysis set A is removed from the reuse instrument 72and placed in storage 80 for patient A's the next treatment. Patientdialysis set B is then removed from the dialysis machine 66 and attachedto the reuse instrument 72 for reprocessing. While patient dialysis setB is being reprocessed, patient dialysis set C may be attached to thedialysis machine 66 and patient C may receive dialysis treatment. Afterpatient C's dialysis treatment is complete, patient dialysis set B isremoved from the reuse instrument 72 and placed in storage 80 forpatient B's the next treatment. Patient dialysis set C is then removedfrom the dialysis machine 66 and attached to the reuse instrument 72 forreprocessing. If patient C is the final patient of the day, patientdialysis set C may be left on the reuse instrument 72 overnight. Thenext morning, patient dialysis set C may be removed from the reuseinstrument 72 and placed in storage 80 for patient C's next treatment.If patient C is not the final patient of the day, the method wouldcontinue as described above for additional patients.

It should be understood that the clinic could treat any number ofpatients without departing from the principals of the present invention.Regardless of the number of patients treated, each patient's dialysisset may be removed from the dialysis machine 66 after use andreprocessed on the reuse instrument 72 prior to the patient's nexttreatment. In this manner the clinic may be simultaneously treating onepatient while reprocessing a different patient's dialysis set, thusincreasing the number of patients the clinic can treat each day.Further, because the extracorporeal circuit 12 always remains attachedto the manifold 56 through the dialyzer 10, and the venous 18 andarterial circuits 16 are not disconnected from the dialyzer 10 aftereach use, the efficiency of the clinic may be increased due to adecrease in labor to assemble and disassemble the extracorporeal circuit12 from the dialyzer 10 for each patient treatment.

It should be understood that the types of connectors 60 used on themanifold 56 may be changed without departing from the invention. Itshould further be understood that the configuration and number ofconnectors 60,62 is based on the type of arterial 16 and venous 18 linesand the dialyzer 10 being used and could be changed in order to adaptthe manifold 56 to be used with any type of arterial 16 and venous 18lines and dialyzer 10 that may be available now or in the future.

For example, inlet (arterial) 16 and outlet (venous) 18 blood lines areknown in the art that contain no air traps 38 or side arms 34,40,44,50.In this case, the only connections from the blood lines 16,18 into themanifold 56 would be the patient end connectors 28,51 such that onceconnected, no residual fluid contained in the extracorporeal circuitcould thereafter drip out. Even in this case, as described previously,the manifold 56 serves as an organizer for the blood lines 16,18 anddialyzer 10 to be conveniently and quickly transported as one unit fromthe dialysis machine 66 to the reuse instrument 72 without the danger ofpossibly contagious patient blood leaving the blood flow path. It alsoprovides a convenient and rapid attachment method to the reuse machine72.

It is also contemplated that the same instrument 72 and associatedcomponents may be used to affect automated priming of the extracorporealcircuit 12 with sterile electrolyte solution prior to treatment. Thisfurther simplifies the reuse process and reduces the amount of labornecessary.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

I claim:
 1. A system for automatically cleaning, disinfecting, testing,and priming an extracorporeal blood circuit for reuse in a dialysismachine comprising: (a) an extracorporeal blood circuit incorporated ina dialysis machine, the extracorporeal circuit comprising: a bloodseparation device, said blood separation device having a blood flowpath, a semipermeable membrane, and a second fluid flow path separatedfrom the blood flow path by the semipermeable membrane, the blood flowpath having a blood inlet and a blood outlet, and the blood separationdevice having at least one port in fluid communication with the secondfluid flow path; a blood outlet line, the blood outline line having adevice end and at least one patient end, the device end being sized andconfigured for engagement with the blood separation device blood outlet;a blood inlet line, said blood inlet line having a device end and atleast one patient end, the device end being sized and configured forengagement with the blood separation device blood inlet; a manifold,said manifold being sized and configured for engagement with the bloodseparation device, the manifold having a plurality of blood lineconnectors, at least one port connector, and at least one reuseconnector, wherein the blood line connectors are sized and configuredfor engagement with one or more patient ends of the blood inlet line andthe blood outlet line; and the at least one reuse connector is sized andconfigured for fluid communication with at least one of the blood lineconnectors; and the port connector is sized and configured forengagement with the port of the second fluid flow path of the bloodseparation device; and (b) a reuse instrument for automaticallycleaning, disinfecting, testing and priming the extracorporeal bloodcircuit, said reuse instrument being configured to connect with themanifold through a first fluid connection with the at least one reuseconnector and a second fluid connection with the at least one portconnector, wherein the manifold is attached to the blood separationdevice and wherein the blood separation device, blood outlet line, bloodinlet line and manifold are removable from the dialysis machine as asingle unit following use for separate processing by the reuseinstrument; and wherein the reuse instrument is adapted to cause fluidtransport across the semipermeable membrane of the blood separationdevice via the first and second fluid connections.
 2. The system ofclaim 1 wherein said blood inlet line includes at least one sidearm,said side arm including a free end; and said manifold includes at leastone connector sized and configured for engagement with the free end ofthe at least one blood inlet line side arm; wherein said manifoldprovides a fluid communication pathway between the blood inlet line andthe side arm.
 3. The system of claim 1 wherein said blood outlet lineincludes at least one side arm, said side arm including a free end; andsaid manifold includes at least one connector sized and configured forengagement with the free end of the at least one blood outlet line sidearm; wherein said manifold provides a fluid communication pathwaybetween the blood outlet line and the side arm.
 4. The system of claim 1wherein said reuse instrument is further adapted to disinfect the bloodinlet line, the blood outlet line, and the blood separation device. 5.The system of claim 1 wherein said reuse instrument is further adaptedto prime the blood inlet line, the blood outlet line, and the bloodseparation device.
 6. The system of claim 1 wherein said reuseinstrument is further adapted to test the blood inlet line, the bloodoutlet line, and the blood separation device for leaks.
 7. A methodcomprising: providing a dialysis machine; providing an extracorporealblood circuit incorporated in a dialysis machine, the extracorporealcircuit comprising: a blood separation device, said blood separationdevice having a blood flow path, a semipermeable membrane, and a secondfluid flow path separated from the blood flow path by the semipermeablemembrane, the blood flow path having a blood inlet and a blood outlet,and the blood separation device having at least one port in fluidcommunication with the second fluid flow path; a blood outlet line, theblood outlet line having a device end and at least one patient end, thedevice end being sized and configured for engagement with the bloodseparation device blood outlet; a blood inlet line, the blood inlet linehaving a device end and at least one patient end, the device end beingsized and configured for engagement with the blood separation deviceblood inlet; a manifold, said manifold being sized and configured forengagement with the blood separation device, the manifold further havinga plurality of blood line connectors, at least one port connector, andat least one reuse connector, wherein the blood line connectors aresized and configured for engagement with one or more patient ends of theblood inlet line and the blood outlet line; the at least one reuseconnector is sized and configured for fluid communication with at leastone of the blood line connectors; and the port connector is sized andconfigured for engagement with the port of the second fluid flow path ofthe blood separation device; providing a reuse instrument forautomatically cleaning, disinfecting, testing and priming theextracorporeal blood circuit, said reuse instrument being configured toconnect with the manifold through a first fluid connection with the atleast one reuse connector and a second fluid connection with the atleast one port connector; coupling the blood separation device to themanifold; coupling the blood inlet line to the blood separation deviceblood inlet; coupling the blood outlet line to the blood separationdevice blood outlet; coupling the manifold to the dialysis machine;coupling the patient end of the blood inlet line and the blood outletline to a patient; providing dialysis treatment to a patient; removingthe manifold from the dialysis machine following the dialysis treatment;and coupling the manifold to a reuse instrument for reprocessing forreuse, wherein the manifold is attached to the blood separation deviceand wherein the blood separation device, blood outlet line, blood inletline and manifold are removable from the dialysis machine as a singleunit following use for separate processing by the reuse instrument; andwherein the reuse instrument is adapted to cause fluid transport acrossthe semipermeable membrane of the blood separation device via the firstand second fluid connections.
 8. The method of claim 7 wherein prior tosaid removing the manifold, further comprising removing the patient endof the blood inlet line and the blood outlet line from the patient; andcoupling the patient end of the blood inlet line and blood outlet lineto the manifold connectors.
 9. The method of claim 8 wherein saidreprocessing further comprises cleaning the blood inlet line, bloodoutlet line, and blood separation device.
 10. The method of claim 9further comprising disinfecting the blood inlet line, blood outlet line,and blood separation device.
 11. The method of claim 9 furthercomprising priming the blood inlet line, blood outlet line, and bloodseparation device.
 12. The method of claim 9 further comprising testingthe blood inlet line, blood outlet line, and blood separation device forleaks.